TRUEplus TRUEplus 5 bevel Pen Needle 32G/4mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00021292010805), received between May 4, 2022 and Mar 3, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “No Flow” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Twisted/Bent; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLES SOMETIMES DID NOT DISPENSE THE INSULIN OR DISPENSED ONLY HALF THE DOSAGE. CUSTOMER ALSO REPORTED THAT THE PEN NEEDLES ARE TOO TIGHT ON HER INJECTION PENS AND AFTER BEING USED THE NEEDLE LOOKS BENT. CUSTOMER IS USING BOTH COMPATIBLE AND NON-COMPATIBLE PRODUCT. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER STATED THAT SHE HAD USED 50 OR MORE OF THE PEN NEEDLES. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495913 ↗
• MalfunctionFeb 9, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. CALLER STATED THAT SOMETIMES THE PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE ON (B)(6) 2025. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294145 ↗
• MalfunctionJan 22, 2026Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THERE IS NO NEEDLE IN THE UNDERNEATH PORTION OF THE PEN NEEDLE TO INSERT INTO THE INSULIN VIAL- THAT NEEDLE IS MISSING. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. PER THE CUSTOMER SHE STARTED USING THE PRODUCT A COUPLE OF WEEKS AGO. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148755 ↗
• MalfunctionNov 24, 2025Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. PER THE CUSTOMER, SHE IS EXPERIENCING AN ISSUE REMOVING SOME OF THE PEN NEEDLES FROM THE INJECTION PEN; CUSTOMER STATED THE PEN NEEDLES DO NOT COME OUT FROM THE COMPATIBLE INJECTOR PEN. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638836 ↗
• MalfunctionAug 15, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES, STATING THAT THE 32G PEN NEEDLES WERE NOT ASPIRATING. THE PACKAGE WAS NOT OPENED OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 WEEK. THE CUSTOMER IS USING COMPATIBLE PRODUCT, AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814632 ↗
• MalfunctionAug 1, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. SON IS CALLING ON BEHALF OF THE CUSTOMER. CALLER STATED THAT AN AIR BUBBLE IS CREATED IN THE PEN NEEDLE WHEN ATTEMPTING TO ADMINISTER INSULIN. CALLER WAS CONCERNED THAT DUE TO THE AIR BUBBLE THE PEN NEEDLE IS NOT DISPENSING THE CORRECT AMOUNT OF INSULIN TO THE CUSTOMER. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CALLER DID NOT RECALL THE EXACT DATE THE CUSTOMER FIRST USED THE PRODUCT OUT OF THIS PACKAGE BUT STATED THERE ARE ONLY ABOUT 5 PEN NEEDLES LEFT IN THE BOX, AS CUSTOMER HAS TO SOMETIMES USE 3-4 BEFORE GETTING ONE THAT WORKS. THE CUSTOMER IS USING COMPATIBLE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687997 ↗
• MalfunctionJul 10, 2025Product Quality Problem; Product Quality Problem

  PHARMACIST REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CALLER STATED THAT ONE OF THE PEN NEEDLES IN THE BOX HAS SOME "FUZZY BLACK STUFF" UNDER THE CAP OF ONE OF THE PEN NEEDLES AND THE NEEDLE IS SEALED UNDER THE PLASTIC WRAPPER. CALLER STATED THAT THE PRODUCT WAS OPENED ABOUT 1 WEEK AGO AND IT WAS LOCATED IN THE BOTTOM OF THE BOX. CALLER ADVISED THAT BOX WAS SEALED AND INTACT UPON RECEIPT. NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473136 ↗
• MalfunctionMar 28, 2025Component Missing; No Flow; Component Missing; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT ONE PEN NEEDLE OUT OF HALF OF THE BOX IS NOT DISPENSING HER INSULIN. CUSTOMER ALSO STATED THAT ONE DID NOT HAVE A NEEDLE. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721942 ↗
• MalfunctionJan 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUE PLUS PEN NEEDLES. BROTHER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE PEN NEEDLES WERE NOT ASPIRATING THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE FOR THE FIRST TIME. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118062 ↗
• MalfunctionNov 15, 2024Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED HE IS UNABLE TO REMOVE THE PEN NEEDLE FROM HIS INJECTOR; CUSTOMER STATED THAT THE CAP WILL NOT COME OFF AT THE TOP HE WILL HAVE TO PULL IT OFF WITH HIS HANDS WHICH IS NOT SAFE. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 WEEK. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696825 ↗
• MalfunctionAug 13, 2024Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PROTECTIVE COVER ON 5 OF THE 32G PEN NEEDLES HAD BEEN MISSING. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER DID NOT DISCLOSE HOW LONG SHE HAS BEEN USING THE PRODUCT. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973150 ↗
• MalfunctionJul 15, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THE 32G PEN NEEDLES ARE NOT DISPENSING HER INSULIN. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS USING 2 DIFFERENT INSULIN PENS, AND BOTH ARE COMPATIBLE WITH THE TRUE PLUS PEN NEEDLES. CUSTOMER ADVISED THAT SHE HAS HAD ABOUT 5 OF THE PEN NEEDLES FORM THE BOX THAT DID NOT WORK. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741553 ↗
• MalfunctionApr 23, 2024Dull, Blunt; Dull, Blunt

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLES WERE DULL. CUSTOMER HAD PURCHASED 300 PEN NEEDLES AND PUT ALL INTO ONE BOX; ADDITIONAL REPORT REFERENCE NUMBERS (B)(4) AND (B)(4). CUSTOMER HAS BEEN USING THE PRODUCT FOR MANY MONTHS. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166643 ↗
• MalfunctionApr 19, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE 32G PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1-2 MONTHS. THE CUSTOMER IS USING COMPATIBLE PRODUCT, AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145095 ↗
• MalfunctionFeb 16, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE PEN NEEDLES ARE NOT DISPENSING HER INSULIN. CUSTOMER HAS 2 BOXES OF THE SAME LOT NUMBER OF PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THE PRODUCT FOR NINE MONTHS. CUSTOMER IS USING COMPATIBLE PRODUCT, AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18725129 ↗
• MalfunctionNov 30, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE 32G PEN NEEDLES WERE NOT ASPIRATING. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE 10/14/2023. THE CUSTOMER IS USING COMPATIBLE PRODUCT, AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236174 ↗
• MalfunctionJun 1, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT SHE IS UNABLE TO GET THE INSULIN OUT OF THE 32G PEN NEEDLES. THE CUSTOMER HAS BEEN USING THIS PRODUCT FOR SEVERAL WEEKS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038711 ↗
• MalfunctionMay 17, 2023Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE NEEDLES KEEP BENDING EVERY TIME SHE TAKES HER INSULIN. CUSTOMER IS UNABLE TO VERIFY THE LOT# OF THE NEEDLES BECAUSE THE PHARMACY GIVES THEM TO HER IN A ZIPLOCK BAG OF 30. CUSTOMER STATES THAT THE NEEDLES ARE FINE WHEN SHE REMOVES THE CAPS, BUT WHEN SHE USES THEM THEY ARE BENT AND IS AFRAID THEY MIGHT BREAK OFF IN HER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. PHARMACY WAS CONTACTED AND PROVIDED THE LOT NUMBER OF THE PEN NEEDLES. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948903 ↗
• MalfunctionMar 14, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE 32G PEN NEEDLES WOULD NOT DISPENSE THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THE PEN NEEDLES OUT OF THIS PACKAGE FOR 3-4 MONTHS. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538550 ↗
• MalfunctionOct 10, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT WHEN SHE TRIES TO INJECT THE INSULIN, SOME OF THE 32G PEN NEEDLES DO NOT HAVE ANY "HOLES" SO THE INSULIN IS NOT BEING DISPENSED WHEN SHE ATTEMPTS TO ADMINISTER. CUSTOMER IS USING COMPATIBLE INSULIN PEN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR A FEW DAYS. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573014 ↗
• MalfunctionJun 28, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT OF INACCURATE ASPIRATION FOR THE 32G PEN NEEDLES. CUSTOMER STATED THE PHARMACY HAD DISPENSED 50 PEN NEEDLES IN A BROWN RX BAG. CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2022. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. CUSTOMER STATED THAT SHE HAS SOME BRUISING AT THE INJECTION SITE IN HER ABDOMINAL AREA. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Bruise/Contusion

  MAUDE report 14843420 ↗
• MalfunctionMay 26, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 32G PEN NEEDLES. CUSTOMER STATED THAT SHE WAS UNABLE TO GET THE INSULIN TO DISPENSE OUT OF THE PEN NEEDLES. CUSTOMER STATED THAT ABOUT HALF OF THE PEN NEEDLES IN THE BOX HAD THIS ISSUE. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE SINCE 04/14/2022. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM THEY WERE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14504575 ↗
• MalfunctionMay 4, 2022Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  CONSUMER REPORTED COMPLAINT FOR THE 32G TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT WHEN HE ADMINISTERS HIS INSULIN, THE NEEDLE IS REALLY SHARP, ALMOST LIKE THERE IS A "BURR" AT THE END OF THE NEEDLES. CUSTOMER STATED IT HURT WHEN HE STICKS THE NEEDLE INTO HIS SKIN. CUSTOMER STATED THE NEEDLE IS MOVING AROUND AS HE IS ADMINISTERING THE MEDICATION, AND THAT HE BELIEVED THIS WAS DUE TO THE NEEDLE NOT GOING IN DEEP ENOUGH. CUSTOMER STATED IT WAS LEAVING WELTS UNDERNEATH HIS SKIN FROM THE FLUID BUILD UP. CUSTOMER STATED THE FLUID LEAKS OUT WHEN HE PULLS THE NEEDLE OUT. AT THE TIME OF THE CALL THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER AND TRANSFERRED CUSTOMER'S INFORMATION TO TECHNICIAN. TECHNICIAN WAS UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 14274423 ↗